Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor.
Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
Tension of an implant is typically adjusted during an implantation procedure sufficiently to take up any slack in the sling and impart at least a degree of increased and efficacious tension or desired positioning of supported tissue. Typically, implants such as urethral tapes or slings are fabricated of a loose weave sling fabric or mesh that engages tissue and encourages tissue ingrowth along the pathway through mesh pores to achieve chronic stabilization or “self-fixation.” Tissue ingrowth can take about 2-3 weeks in a typical patient in the absence of any significant intentional or unintentional movement of the mesh. During this post-operative time, the patient monitors the degree of success achieved in ameliorating symptoms of incontinence (e.g., urinary leakage) and any discomfort that might occur if the applied tension is so high as to unduly slow voluntary urination (for treating urinary incontinence). If any such problems occur it may be necessary to reopen the original surgical incisions to access and pull on the implant ends to tighten the central portion around the urethra (or other tissue being supported) or to on the implant central support portion to loosen the central support portion around the urethra. Several approaches have been taken to simplify or reduce the need for such post-operative adjustments.
Although effective in alleviating incontinence (e.g., anal, SUI), improvements in urethral and anal slings and other pelvic floor implants to post-operatively adjust tension applied to the urethra, anus, or other pelvic floor tissue, are desirable.